Role : Manufacturing Engineer

Location : Mounds view, MN

Duration : Contract

Need candidate from Medical domain side

Keywords : Risk assessment, Labeling , TMV,Production control, CAPA, DFMEA, PFMEA, IQ/OQ/PQ, , QSR 21 CFR 820, ISO 13485, ISO 14971, Track wise

2. Review and approve the documents required to qualify through production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
3. Good experience in CAPA process.
4. Measurement System Analysis / Test method Validation
5. Test protocol and report preparation
6. Review and approve the documents required to qualify through production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
7. Good experience in CAPA process.
8. Measurement System Analysis / Test method Validation
9. Test protocol and report preparation
10. Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.
11. Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan
12. Route PPAP Checklist in Agile
13. Leverage GMP (Good Manufacturing Practices). Navigates the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.
14. PPAP experience
15. Supplier document review and approve per MDT process
16. Supplier control and management
17. Work closely with supplier
18. Track wise and MAP agile experience
19. Critical component identification and qualification
20. Perform receiving inspection
21. Driving supplier activities
22. Leadership toward supplier activities and interaction